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Data / Medical devices / Biopsy Needle / United States

FDA-registered makers of Biopsy Needle in the United States: 27 establishments

27 establishments in the United States are registered with the FDA to make Biopsy Needle (product code FCG). 12 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.

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Device
Biopsy Needle
Product code
FCG
Country
United States

Makers of Biopsy Needle in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Covidien llcSanta Clara, CA, United StatesSpecification developer4April 26, 2018000api.fda.gov
Merit Medical Systems, Inc.South Jordan, UT, United StatesSpecification developer3August 7, 2015000api.fda.gov
Bard Peripheral Vascular, Inc.Tempe, AZ, United StatesSpecification developer2March 22, 1994050api.fda.gov
Cook IncorporatedSpencer, IN, United StatesComplaint file establishment, Manufacturer2July 14, 1997000api.fda.gov
Argon Medical Devices Inc.Athens, TX, United StatesManufacturer1June 22, 2001000api.fda.gov
Boston Scientific CorporationMarlborough, MA, United StatesComplaint file establishment, Specification developer1October 22, 2015020api.fda.gov
Boston Scientific CorporationSpencer, IN, United StatesManufacturer1October 22, 2015010api.fda.gov
Boston Scientific CorporationCoventry, RI, United StatesManufacturer1October 22, 2015000api.fda.gov
Cook IncorporatedBloomington, IN, United StatesComplaint file establishment, Manufacturer, Manufacturer for export1July 14, 1997010api.fda.gov
Gyrus ACMI, Inc.Brooklyn Park, MN, United StatesManufacturer1March 22, 2016000api.fda.gov
United States Endoscopy Group, Inc.Mentor, OH, United StatesComplaint file establishment, Manufacturer1June 20, 1997000api.fda.gov
Wilson-Cook Medical Inc.Winston Salem, NC, United StatesComplaint file establishment, Manufacturer1August 4, 2017010api.fda.gov
Ad-Tech Medical Instrument Corp.Oak Creek, WI, United StatesManufacturer0000api.fda.gov
Argon Medical Devices, Inc.Wheeling, IL, United StatesContract manufacturer0000api.fda.gov
Boston Scientific Corp., Marina Bay Cust. Fulfillment CenterQuincy, MA, United StatesManufacturer0000api.fda.gov
Carefusion 2200, Inc.Vernon Hills, IL, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Carefusion 2200, Inc.Mannford, OK, United StatesContract manufacturer0000api.fda.gov
Freudenberg Medical, LLCJeffersonville, IN, United StatesContract manufacturer0000api.fda.gov
Gyrus Acmi, Inc.Westborough, MA, United StatesSpecification developer0000api.fda.gov
Ispg, Inc.Lakewood Ranch, FL, United StatesContract manufacturer0000api.fda.gov
Needle Specialty ProductsBoyle, MS, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - Mansfield, BridgemedicaMansfield, MA, United StatesContract manufacturer0000api.fda.gov
RLS Interventional Inc. DBA InradGrand Rapids, MI, United StatesManufacturer0000api.fda.gov
Ranfac Corp.Avon, MA, United StatesContract manufacturer, Manufacturer0000api.fda.gov
Spartronics Watertown LLCWatertown, SD, United StatesContract manufacturer0000api.fda.gov
Teleflex Medical LLCMorrisville, NC, United StatesComplaint file establishment, Specification developer0000api.fda.gov
Vascular Solutions LLCMaple Grove, MN, United StatesSpecification developer0000api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.